UMIN-CTR Clinical Trial

Public title

Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.

Acronym

Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.

Scientific Title

Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.

Scientific Title:Acronym

Corticosteroids for patients with acute respiratory distress syndrome; systematic review and meta-analysis.

Region

Japan

Condition

Acute respiratory distress syndrome

Classification by specialty

Pneumology

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the benefit and harms of steroids versus placebo or conservative therapy for patients with acute respiratory distress

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Hospital mortality, the number of ventilator free days, and incidence of infection.
If there will be no data of hospital mortality, we will collect 28-60days mortality as short-term mortality. Incidence of infection will collect data of the number of patients with infection during hospital stay. Hospital mortality and incidence of infection will integrate risk ratio. VFDs will integrate mean difference.

Key secondary outcomes

ICU mortality, ICU length of stay (LOS), hospital LOS, ventilator days and oxygenation.
We will collect data of P/F ratio on study day 7 as oxygenation. ICU mortality will integrate risk ratio. ICU LOS, hospital LOS, ventilator days and P/F ratio will integrate mean difference.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ARDS, which was diagnosed by American European Consensus (1994) or Berlin (2012) diagnosis criteria. We will also include patients with acute respiratory failure which is defined as follow:
- An acute onset of hypoxemia, with P/F ratio 200 mmHg and less
- Bilateral noncardiogenic pulmonary edema
- No clinical evidence of increased left atrial hypertension or a pulmonary artery wedge pressure 18 mmHg and less in the presence of a pulmonary artery catheter.

Key exclusion criteria

- Cardiac edema
- Hypercapnia without hypoxia
- Contraindication of steroids
- Diseases which steroids is effective
- History of steroids use by some months before inclusion
- No ventilation
- Acute lung injury associated with immaturity and congenital malformations

Target sample size

0

Name of lead principal investigator

1st name	Shodai
Middle name
Last name	Yoshihiro

Organization

JA General Hospital

Division name

Pharmaceutical department

Zip code

738-8503

Address

1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN

TEL

0829-36-3111

Email

syoshihiro-ja@umin.ac.jp

Name of contact person

1st name	Shodai
Middle name
Last name	Yoshihiro

Organization

JA General Hospital

Division name

Pharmaceutical department

Zip code

738-8503

Address

1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN

TEL

0829-36-3111

Homepage URL

Email

syoshihiro-ja@umin.ac.jp

Institute

JA General Hospital.

Institute

Department

Personal name

Organization

N/A.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Pharmaceutical department, JA General Hospital

Address

1-3-3 jigozen, hatsukaiti-shi, HIROSHIMA 738-8503 JAPAN

Tel

0829-36-3111

Email

syoshihiro-ja@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

07

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2020

Year

06

Month

30

Day

Date of IRB

Anticipated trial start date

2020

Year

07

Month

05

Day

Last follow-up date

2020

Year

07

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Types of study to be included.
We will include any randomized controlled trials.

2. Searches.
The following electronic database will be used; MEDLINE, CENTRAL, and ICHUSHI Web.

3. Risk of bias assessment.
Risk of bias will be classified as high, low or unclear by 2 or more reviewers. Any disagreements are resolved by discussion among reviewers. We will assess selection performance, detection attrition and reporting bias, and other potential risks of bias.

4. Strategy for data synthesis.

4.1. Summary measures
Collected variables will be synthesized by using random-effects methods. We will create a 'Summary of findings table' using follow seven outcomes; hospital mortality, VFDs, incidence of infection, ICU mortality, ICU LOS, hospital LOS, and data of P/F ratio. Each outcomes will be checked the certainty of the evidence by risk of bias, inconsistency/heterogeneity, indirectness, imprecision and publication bias. Our conclusion will be presented by a Summary of findings table.

4.2. Assessment of heterogeneity
We will assess heterogeneity by using visual inspection of forest plot, I2 statics and Cochran's Q statistic.

4.3. Subgroup analysis
We will conduct subgroup analysis about timing, anti-inflammatory potency, duration of steroids and age for the primary outcomes. The anti-inflammatory potency will be divided into three categories of methylprednisolone equivalents. We will categorize duration of steroids by considering half-life of steroids. Age will divide into 18 and more years old or less than 18.

4.4. Publication bias
Publication bias will be accessed by funnel plot and will use Egger's test (p value of less than 0.05 for a two-sided test) to assess reporting bias when 10 or more studies will be synthesized.

4.5. Sensitivity analysis
We will exclude studies that do not clearly show compliance with the low tidal ventilation strategy and studies with the sequential stopping rule and high risk of bias for the primary outcomes.

Registered date

2020

Year

07

Month

05

Day

Last modified on

2020

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046815